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Onovus Solo Open

by Ostique Limited United Kingdom EUDAMED

Ref OST45MI/S

EMDN A1001020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50700004937OST45M/SH6 Basic UDI-DIDate28 Oct 2024RegisteredStatusWithdrawn

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Onovus Solo Ostomy Bag
Model / Reference
OST45MI/S
Primary DI / UDI-DI
05070000493725
Basic UDI-DI
50700004937OST45M/SH6
EMDN Code
A1001020102 One-piece ileostomy bags for non-retracted stoma, flat, with tissue cover
Device Class
Class I
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000030059
Authorised representative
Compliant MD Cyprus Ltd CY-AR-000044483

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f79ee9a2-0021-4ff2-b886-f76641586750 61 fields · synced 22 Oct 2026